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About the Author

Michelle Lott is the Principal and Founder of Lean RAQA, a regulatory and quality consultancy for medical device companies. Michelle currently serves a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP); reviewing feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices. Michelle achieved a Regulatory Affairs Professionals Society Executive Leadership Certification from Northwestern Kellogg School of Management and a BS in Chemistry from Troy State University. Interesting fact: Michelle formerly served as an expert witness in forensic toxicology at the Mississippi Crime Laboratory.

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